(88 days)
Not Found
No
The summary describes a mechanical orthopedic implant system and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is a medical implant (prosthesis) designed to replace parts of the femur and tibia, indicated for conditions like knee instability, bone loss, and deformities, which directly addresses disease or injury.
No
This device is a surgical implant designed to replace bone in cases of extensive resection and restoration, not to diagnose medical conditions.
No
The device description clearly describes physical implants (proximal femur, mid-shaft femur, distal femur, proximal tibia, total knee components) and mentions non-clinical performance testing related to fatigue of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this device is a surgical implant intended to replace parts of the femur and tibia (bones) and the knee joint. It is used within the body during surgery to address structural issues and instability.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This Segmental System is indicated for:
- Significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the proximal and/or distal femur and/or proximal tibia
- Valgus, varus or flexion deformities
- The salvage of previously failed surgical attempts
- A total femoral replacement construct consisting . of the MOST Options or Segmental proximal femoral, Segmental System segments and Segmental System distal femoral components may be used without cement.
- Variable Stiffness stem extensions require the . use of either a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem, the smooth collar must be cemented against the bone. The remainder of the stem must be used uncemented.
- Fluted stem extensions require the use of either a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem extension, the smooth collar must be cemented against the bone. The remainder of the stem must also be cemented against the bone.
- The Trabecular Metal collar may be used . cemented or uncemented against the bone.
- All other constructs are for cemented use only.
This device is indicated for:
- Moderate to severe knee instability
- Significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, collagen disorders, and/or avascular necrosis of the proximal and/or distal femur and/or proximal tibia.
- Valgus, varus or flexion deformities
- The salvage of previously failed surgical attempts
- A total femoral replacement construct consisting of the MOST Options® or Segmental proximal femoral, Segmental System segments and Segmental System distal femoral components may be used without cement.
- Variable Stiffness stem extensions require the use of either a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem, the smooth collar must be cemented against the bone. The remainder of the stem must be used uncemented.
- Fluted stem extensions require the use of either a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem extension, the smooth collar must be cemented against the bone. The remainder of the stem must also be cemented against the bone.
- The Trabecular Metal collar may be used cemented or uncemented against the bone.
- All other constructs are for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
KRO, LZO, JDI, LPH, LWJ, KWZ, KWL, KWY
Device Description
The Zimmer Segmental System is intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia and/or total knee in cases that require extensive resection and restoration. The Segmental System provides for cross compatibility between selected components from the MOST Options® System and NexGen® Rotating Hinge Knee System. A total mid-calf to hip replacement can be achieved using the Segmental System. The cleared distal femoral component and the proposed proximal tibial component are designed to be compatible with standard NexGen patella components. The proximal femoral components are designed to be compatible with various Zimmer femoral heads with a 12/14 taper.
The Trabecular Metal Proximal Femoral Component is designed to replace the proximal femur and is available in two sizes (38mm and 46mm offsets). The Trabecular Metal Proximal Tibial Component is designed to replace the proximal tibia and is available in three sizes. The Segment with Male/Female Taper components are designed to be used with Segmental System Stem Extensions in combination with a proximal femoral component, a distal femoral component, and/or a proximal tibial component, or intercalary segments, in order to replace portions of the proximal femur, mid-shaft femur, distal femur, and/or proximal tibia.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal femur, mid-shaft femur, distal femur, proximal tibia, total knee, proximal and/or distal femur and/or proximal tibia, hip, knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance and Conclusions:
The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices. Performance testing included: proximal femoral component fatigue test, proximal tibial component fatigue test, segment component fatigue test.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K070978, K101296, K964350, K013031, K013385
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains a logo and some handwritten text. The logo is a circle with a stylized letter "Z" inside, and below it, the word "zimmer" is printed in a bold, sans-serif font. To the left of the logo, there is handwritten text that appears to be "K110940" and "p.1/4".
JUL - 1 2011
Summary of Safety and Effectiveness
| Sponsor: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mark D. Warner
Specialist, Regulatory Affairs
Telephone: 574-372-4150
Fax: (574) 372-4605 |
| Date: | April 1, 2011 |
| Trade Name: | Zimmer® Segmental System Trabecular Metal™
Proximal Tibial Component, Trabecular Metal
Proximal Femoral Component, and additional
Segment with Male/Female Taper components |
| Common Name: | Total Hip Prosthesis (proximal femoral component,
segment components) |
| | Total Knee Prosthesis (proximal tibial component,
segment components) |
| Classification Name and Reference: | LPH - Prosthesis, Hip, Semi-Constrained,
Metal/Polymer, Porous Uncemented;
21 CFR § 888.3358 |
| | LWJ - Prosthesis Hip, Semi-Constrained,
Metal/Polymer, Uncemented; 21 CFR § 888.3360 |
| | JDI - Prosthesis, Hip, Semi-Constrained,
Metal/Polymer, Cemented; 21 CFR § 888.3350 |
| | LZO - Prosthesis, Hip, Semi-Constrained,
Metal/Ceramic/Polymer, Cemented or Non-Porous,
Uncemented; 21 CFR § 888.3353 |
| | KWY - Prosthesis, Hip, Hemi-, Femoral,
Metal/Polymer, Cemented or Uncemented;
21 CFR § 888.3390 |
1
110940 $ 2/4
Predicate Devices:
Device Description:
KWL - Prosthesis, Hip, Hemi-, Femoral, Metal; 21 CFR § 888.3360
KWZ - Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/Polymer; 21 CFR § 888.3310
KRO - Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer; 21 CFR & 888.3510
Zimmer Segmental System, manufactured by Zimmer Inc. (K070978, cleared July 3, 2007)
Zimmer Segmental System Proximal Femoral Component, manufactured by Zimmer Inc. (K101296, cleared July 30, 2010)
MOST System, manufactured Intermedics Orthopedics, Inc. (K964350, cleared January 16, 1997)
MOST Options System, manufactured Sulzer Orthopaedics (K013031, cleared December 7, 2001)
NexGen® Complete Knee Solutions Rotating Hinge Knee System, manufactured by Zimmer, Inc. (K013385, cleared January 9, 2002)
The Zimmer Segmental System is intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia and/or total knee in cases that require extensive resection and restoration. The Segmental System provides for cross compatibility between selected components from the MOST Options® System and NexGen® Rotating Hinge Knee System. A total mid-calf to hip replacement can be achieved using the Segmental System. The cleared distal femoral component and the proposed proximal tibial component are designed to be compatible with standard NexGen patella components. The proximal femoral components are designed to be compatible with various Zimmer femoral heads with a 12/14 taper.
The Trabecular Metal Proximal Femoral Component is designed to replace the proximal femur and is available in two sizes (38mm and
2
K110940 08/4
Intended Use:
46mm offsets). The Trabecular Metal Proximal Tibial Component is designed to replace the proximal tibia and is available in three sizes. The Segment with Male/Female Taper components are designed to be used with Segmental System Stem Extensions in combination with a proximal femoral component, a distal femoral component, and/or a proximal tibial component, or intercalary segments, in order to replace portions of the proximal femur, mid-shaft femur, distal femur, and/or proximal tibia.
This Segmental System is indicated for:
-
- । Significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the proximal and/or distal femur and/or proximal tibia
- Valgus, varus or flexion deformities ।
- । The salvage of previously failed surgical attempts
- A total femoral replacement construct consisting . of the MOST Options or Segmental proximal femoral, Segmental System segments and Segmental System distal femoral components may be used without cement.
- Variable Stiffness stem extensions require the . use of either a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem, the smooth collar must be cemented against the bone. The remainder of the stem must be used uncemented.
- . Fluted stem extensions require the use of either a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem extension, the smooth collar must be cemented against the bone. The remainder of the stem must also be cemented against the bone.
- The Trabecular Metal collar may be used . cemented or uncemented against the bone.
- All other constructs are for cemented use only. .
3
Comparison to Predicate Device:
K110940
p4/4
Performance Data (Nonclinical and/or Clinical):
The proposed Segmental System components are similar or identical in intended use, materials, sterility, and performance characteristics to the predicate devices.
Non-Clinical Performance and Conclusions:
The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices. Performance testing included: proximal femoral component fatigue test, proximal tibial component fatigue test, segment component fatigue test.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle. The eagle is drawn with thick, black lines, and the text is in a simple, sans-serif font.
Food and Drug Administration 10903 New Hamoshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zimmer, Inc. % Mr. Mark D. Warner Specialist, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
JUL - 1 2011
Re: K110940
Trade/Device Name: Zimmer Segmental System Trabecular Metal Proximal Tibial Component. Trabecular Metal Proximal Femoral Component, and additional sizes of Male-Female Segments
Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: II Product Codes: KRO: LZO, JDI, LPH, LWJ, KWZ, KWL, KWY Dated: April 1, 2011 Received: April 4, 2011
Dear Mr. Warner:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
5
Page 2 – Mr. Mark D. Warner
CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
E.J. Keith
Fr Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
KI10940
510(k) Number (if known):
Device Name:
Zimmer Segmental System Trabecular Metal Proximal Tibial Component, Trabecular Metal Proximal Femoral Component, and additional Segment with Male/Female Taper components
Indications for Use:
- · This device is indicated for:
- Moderate to severe knee instability ເ
- Significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, । rheumatoid arthritis, osteoarthritis, traumatic arthritis, collagen disorders, and/or avascular necrosis of the proximal and/or distal femur and/or proximal tibia.
- Valgus, varus or flexion deformities -
- । The salvage of previously failed surgical attempts
- · A total femoral replacement construct consisting of the MOST Options® or Segmental proximal femoral, Segmental System segments and Segmental System distal femoral components may be used without cement.
- · Variable Stiffness stem extensions require the use of either a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem, the smooth collar must be cemented against the bone. The remainder of the stem must be used uncemented.
- · Fluted stem extensions require the use of either a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem extension, the smooth collar must be cemented against the bone. The remainder of the stem must also be cemented against the bone.
- · The Trabecular Metal collar may be used cemented or uncemented against the bone.
- · All other constructs are for cemented use only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
। ર
(Please do not write below this line -- Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| for M. Melkeron | Page 1 of 1 | |
|---|---|---|
| -- | ----------------- | ------------- |
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
| 510(k) Number | K110940 |
|---|---|
| --------------- | --------- |